AP Story: ABOUT THE RECALL: Some lots of the blockbuster anemia treatments Epogen and Procrit were recalled because the injected drugs may contain glass flakes. Those could cause blood clots, swelling of veins, immune system reactions and other problems. HOW IT HAPPENED: Amgen Inc. says the flakes are caused by the interaction of the drug with glass vials over the product's shelf life. WHAT PATIENTS CAN DO: Patients experiencing problems should contact their doctor. The lot numbers and expiration dates can be found on websites for the products, and patients can call 1-800-77-AMGEN to ask questions. ------------ Didn't we have this problem before, back in the '90s. The problem was not product interaction. It was the vial sealing materials that caused the problem.
Yeah but no one is around to remember it. And this time, QA/QC screwed up, let defective product ship and it had to be recalled.
Plant Manager here- this was done to boost slumping Aranesp sales. Who says sales dive the market place!!
No. They can't make Procrit, they can only make Eprex. Maybe they can get approval for Eprex in the US.
According to regulatory the licensing agreement allows for JNJ to make Procrit in the US if Amgen doesnt supply. I dont think this was meant to boost sales of Aranesp. JnJ can really screw us here
Its complicated. The sales are negotiated because we divide procrit/epogen sales to make sure that procrit is oncology and epogen is renal. We have been able to track procrit sales which helps aranesp strategically target their accounts. We charge jj for manufacturing costs but they would rather make it themselves for cheaper and not give the free intel. There is supposedly clause to let jj make procrit if amgen does not supply. Their lawyers might litigate over this. However I wouldnt trust them to make anything.
This is the reason why Kevin sent two VP's to AML as expats and is bringing more expats from TO. Thanks God it was nothing to worry about.
This is old news from back in September. Lots should have been recalled by now, and action plan should be in place to prevent reocurrance. WHAT PATIENTS CAN DO: Patients experiencing problems should contact their doctor. The lot numbers and expiration dates can be found on websites for the products, and patients can call 1-800-77-AMGEN to ask questions.
I know a little about protein chemistry, and I find it hard to believe that a dilute protein solution like vialed Epogen can cause glass to flake. If it did, I certainly not want it injected into my veins.
I would love to see the report that identifies the flakes as "glass"! This is total BS and they have known about this problem for years and it is not "glass" my friends.
Hey foolios...the vials are chipped during shipment! During shipment to the coveted AML site, the vials bump around in their container causing them to chip, according to Amgen. 100% inspection does not work and thus the vials get filled and shipped to patients. The brilliance of senior management is to blame BD, the vial manufacturer, but now the VP of Quality MVT wants to source plastic vials to cover for the waste of AML; outsource all work to BI and GSK Amgen...time to wake up and get a clue. A great company no more...arrogance at all levels of the organization. I hope BB and JP start to have skip-skip-skip-skip level meetings to get the truth. VPs cover for EDs and EDs cover for directors. Hey McKinsey consultants...time to flatten the organization...unless KS wants the fat to claim savings during a PMI with another POS.
Dude get it right, BD only makes syringes not vials, I guess now we know how reliable is the rest of your info.
The sodium citrate buffer is probably causing delamination of the glass. It is a well known phenomenon. Why wasn't this picked up sooner?
